Improving Outcomes in Cardiac Arrest With Inhaled Nitric Oxide

Cardiac Arrest Clinical Trial

Official title:

Improving Outcomes in Cardiac Arrest With Inhaled Nitric Oxide

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04134078
• Other study ID #: 648019
• Status: Recruiting
• Phase: Early Phase 1
• Start date: August 2016
• Est. completion date: July 2022

Study information

• Verified date: October 2019
• Source: Stony Brook University
• Contact: Jignesh Patel, MD
• Email: jignesh.patel[@]stonybrookmedicine.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Sudden cardiac arrest (CA) is a leading cause of death worldwide. CA claims the lives of an estimated 300,000 Americans each year. Despite advances in cardiopulmonary resuscitation (CPR) methods, only approximately 10% of adults with CA survive to hospital discharge, and up to 60% of survivors have moderate to severe cognitive deficits 3 months after resuscitation. Most of the immediate and post-CA mortality and morbidity are caused by global ischemic brain injury. The goal of this grant application is to test the hypothesis that resuscitation from cardiac arrest can be improved by improving cerebral oxygenation through inhalation of nitric oxide. This strategy will also improve the chances of return of spontaneous circulation (ROSC), improve short-term survival and neurologic outcome.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: July 2022
• Est. primary completion date: July 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Age 18 years and above

2. In-hospital cardiac arrest as defined by cessation of heartbeat

3. Presence of Endotracheal Tube

Exclusion Criteria:

1. Age below 18 years

2. Absence of Endotracheal Tube

3. Patients with out-of-hospital cardiac arrest

4. Patients involved in trauma and/or patients in the SICU or CTICU

5. Preexisting intra-cerebral lesions such as any head injury (old or new), brain hematoma, cerebral hemorrhage or known frontal lobe disorders such as tumors

6. Any patient with a terminal condition that cannot be treated (specifically any terminal malignancy, end stage lung fibrosis, chronic heart failure with an ejection fraction <20%)

7. Patients with do not resuscitate and/or do not intubate (DNR/DNI) status

8. Therapeutic window has passed

Related Conditions & MeSH terms

• Cardiac Arrest
• Heart Arrest

Intervention

Drug:
• inhaled nitric oxide
Inhaled nitric oxide at 40 ppm will be administered upto 24 hours post ROSC in patient who developed in hospital cardiac arrest

Locations

Country	Name	City	State
United States	Stony Brook University	S. Setauket	New York

Sponsors (1)

Lead Sponsor	Collaborator
Stony Brook University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of return of spontanueous circulation (ROSC)	The primary outcome measure is to evaluate rates of return of spontaneous circulation (ROSC) from in hospital cardiac arrest patient who receive inhaled nitric oxide	1 day
Primary	Change in cerebral oxygenation (rSO2)	The outcomes measure is to evaluate change in the concentration of cerebral oxygenation measured by Near-infrared spectroscopy before and after the administration of inhaled nitric oxide	1 day
Secondary	Neurologic outcomes at hospital discharge	Patient who suffered in hospital cardiac arrest has variable neurologic outcomes. This will be evaluated with Glasgow outcome scale (GOS). This score ranges from 1 to 5 where GOS 1-3 is considered unfavourable neurologic outcomes and GOS 4-5 are considered favourable neurologic outcomes.	upto 24 weeks
Secondary	short term survival	Short term survival will include survival from hospital to discharge	upto 24 weeks